Damián Triay DíazLABIOFAM Business Group, Cuba
Title: Post-Marketing Surveillance of VIDATOX® 30CH, Cuba (2013-2018)
Introduction: VIDATOX® 30CH, a homeopathic medicine, is obtained from the mother tincture of the venom of the scorpion Rhopalurus junceus. It is indicated as a complementary therapy for treating symptoms caused by the effects of cancer and for pain relief.
Objective: To describe the use and safety of the drug VIDATOX® 30CH, during its post-marketing surveillance.
Methods: An observational, descriptive and retrospective study was carried out about the practical consequences of using VIDATOX® 30CH in Cuba. The consumption of the product was obtained from the sales report of the National Drug-Marketing Company. Its safety was evaluated through the reports of adverse reactions to drugs from the Cuban Pharmacovigilance System, from 2013 to the end of 2018. Adverse reactions were characterized according to clinical and demographic variables.
Results: Until 2018, 1 167 522 units of VIDATOX® 30CH were sold. 2014 was the year with the highest sales. There were 64 adverse reactions reported; primary care level reported 87.5%. Male adults aged 61-75 years were the most affected. The digestive system reported 53.1% of adverse reactions, while abdominal pain was the most frequent symptom (18.7%). Moderate-intensity reactions accounted for 68.7%, and no serious ones were reported. There were an 87.5% classified as conditional reactions, while only 4.3% (3) were classified as frequent reactions.
Conclusions: VIDATOX® 30CH did not present serious adverse reactions and is beneficial in the treatment of diseases that cause pain and inflammation.
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